A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease

A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease; A Prospective, Randomized, Parallel, Open-Label, Single-center, Phase IV Clinical Trial

This study is to compare the effects of sarpogrelate sustained release /aspirin combination therapy versus aspirin on blood viscosity in the patients with peripheral arterial disease and coronary artery disease

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Blood Viscosity; Sarpogrelate
• Intervention / Treatment: Drug: Sarpogrelate Sustained Release/Aspirin; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Uijeongbu, Gyeonggi-do, Korea, Republic of, 11765
      • The Catholic University of Korea Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Both man and woman who is over 19 years old
2. Identified as 10-75% of Stenosis in Coronary Angiography or Coronary CTA(Coronary computed tomography angiography)
3. Patients who diagnosed with peripheral artery disease or has symptoms
4. Written informed consent

Exclusion Criteria:

1. Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.
2. Patients who have taken aspirin within two weeks before randomization
3. Patients who need antiplatelet or anticoagulant medication except Aspirin

4. Confirmed below results at screening

   • Hemoglobin <13g/dL
   • Platelet <60,000/µL
   • Severe kidney disease patient with eGFR(estimated Glomerular Filtration Rate) <30 mL/min/1.73 m2 (CKD-EPI)
5. Patients with a history of cerebrovascular and cardiovascular complications (brain infarction, transient cerebral ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary artery intervention) within the last six months
6. Patients with bleeding
7. Pregnant or lactating women
8. Those participating in other clinical trials for investigational products
9. Patients deemed to be ineligible to participate in the trial by investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarpogrelate Sustained Release/Aspirin; Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks	Drug: Sarpogrelate Sustained Release/Aspirin; Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks
Active Comparator: Aspirin; Aspirin Monotherapy qd for 12 weeks	Drug: Aspirin; Aspirin 100mg qd for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer	Baseline/Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer	Baseline/Week 4
Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method	Baseline/Week 4/Week 12
Change from baseline to week 4, 12 in Erythrocyte Aggregation(critical shear stress) measured by Microfluidic Scanning Method	Baseline/Week 4/Week 12
Change from baseline to week 4, 12 in FMD(Flow Mediated Dilation) by Endothelium-dependent vasodilation measurement	Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in tODI(tissue oxygen delivery index)	Baseline/Week 4/Week 12
Proportion of subjects who tODI(tissue oxygen delivery index) have improved by 20% or more	Week 12
Rate of change from baseline to week 4, 12 in Lipid profile	Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in FPG(Fasting Plasma Glucose)	Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)	Baseline/Week 4/Week 12
Rate of change from baseline to week 4, 12 in hs-CRP(high sensitivity C-Reactive Protein)	Baseline/Week 4/Week 12
Change from baseline to week 12 in SF-36(Questionnaire for Medical Outcome Short Form Health Survey, 36-Item)	Baseline/Week 12
Change from baseline to week 12 in VAS(Visual Analogue Scale)	Baseline/Week 12

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: KeunSang Yum, The Catholic University of Korea Uijeongbu St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Sarpogrelate Sustained Release
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Serotonin Antagonists; Serotonin Agents; Aspirin; Sarpogrelate
• Other Study ID Numbers: YMC047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No